510(k) K955473 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
GAMMA SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 16, 1996 |
| Received | Nov 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955473
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 3 consists of all products under product code JDI, and same usage:
Item no:781803800 12/14 UNIPOLAR FEMORAL HE
781804000 12/14 UNIPOLAR FEMORAL HE
781804100 12/14 UNIPOLAR FEMORAL HE
781804200 Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 67 consists of all product under product code: JDI and same usage:
Item no:
785001100 VERSYS ADVOCATE CEMENTED
785001200 VERSYS ADVOCATE CEMENTED
785001220 VERSYS ADVOCATE CEMENTED
785001300 Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 71 consists of all product under product code: JDI and same usage:
Item no:
783401000 VERSYS PRESS FIT LD/FX ST
783401100 VERSYS PRESS FIT LD/FX SZ
783401200 VERSYS PRESS FIT LD/FX SZ
7834013 Terminated |
JDI | None listed |
| Aug 26, 2014 | Zimmer, Inc. Endo & Unipolar Femoral Heads:
ENDO FEMORAL HEAD 41MM DIA
ENDO FEMORAL HEAD 42MM DIA
ENDO FEMORAL HEAD 43MM DIA
ENDO FEMORAL HEAD 44MM DIA
ENDO FEMORAL HEAD 45MM DIA
ENDO FEMORAL HEAD 46MM DIA
ENDO FE Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. 12/14 UNIPOLAR FEMORAL HE
VERSYS CEM LD/FX SZ 11X12
VERSYS CEM LD/FX SZ 12X12
VERSYS CEM LD/FX SZ 14X13
VERSYS CEM LD/FX SZ 16X14
VERSYS CEM LD/FX ST 18X15
VERSYS PRESS FIT LD/FX ST
VERSYS PRESS FIT L Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.